Definition of relevant material

This page sets out guidance on the definition of what the Human Tissue Act (2004) (HT Act) refers to as ‘relevant material’. This definition excludes human application.

Issued 18 December 2008

The definition of relevant material in the HT Act is:

Section 53: Relevant material

1. In this Act, "relevant material" means material, other than gametes, which consists
of or includes human cells.

2. In this Act, references to relevant material from a human body do not include:

(a) embryos outside the human body, or
(b) hair and nail from the body of a living person.

The Act’s use of the words “…or includes human cells” in its explanation of the term suggests that Parliament meant it to be comprehensive. Hansard records a Ministerial statement that the term applied irrespective of the number of cells in the material. The Authority considered that a definition which reinforced this clear legislative intent was required. It noted that the Act did not attempt to limit or modify the scope of the need for consent according to the use to which the material was to be put or how it might be classified by those storing it or using it. In response to the suggestion from some commentators that bodily waste products containing cells might be exempted from relevant material status, the Authority took the view that the consent requirements stemming from relevant material status were entirely appropriate.

Categories of relevant material

The Authority considers it helpful to divide potentially relevant material into four categories.
This categorisation helps in determining whether a sample is relevant material. However, the fundamental principle remains that if a sample is known to contain even a single cell that has come from a human body, then the sample should be classified as relevant material.
The categories of relevant material are:

1. Specifically identified relevant material

This includes material like bodily organs and tissues, consisting largely or entirely of cells, and clearly identifiable and regarded as such. This category of relevant material includes human bodies, internal organs and tissues, skin and bone.

2. Processed material

Where a processed material is generally agreed – as a result of the process – to leave it always either cellular or acellular, then the presumption should be that all examples should be regarded as such. The HTA would rely on an assurance that the process in question had been carried out. Under this category plastinated tissue and plastinated body parts (where the cellular structure is retained by the plastination process) are to be regarded generically as relevant material; while plasma or serum, for example, will be regarded as not. The two latter processed materials, widely produced from blood taken for diagnostic investigations, are however examples of where ‘normal expectations’ may well need to be exercised.

3. Bodily waste products (including excretions and secretions)

Bodily waste is a less well characterised group of material. Nevertheless the Authority considers it important to provide a framework of guidance. The Authority considers bodily waste should normally be regarded as relevant material: the Act cannot be denied on this point. The Act’s wording is clear and reflects the possibility that even a single cell can be subject to research. While acknowledging the views of stakeholders who have argued for greater individual discretion, it would be inappropriate to encourage people to grant themselves an exemption on the basis of their own interpretation of the Act. However the
Authority may be able to offer nuanced advice in specific instances. There will be cases where a researcher believes that material, intended for a scheduled purpose, is actually acellular. In such cases the researcher would need to consult the Authority, and we would then refer the case for advice to a members’ panel if necessary.

4. Cell deposits and tissue sections on microscope slides

In general cell deposits or tissue sections on microscope slides are considered to constitute relevant material. This is because such deposits or sections are likely to contain whole cells or are intended to be representative of whole cells.

Supplementary list of materials

To supplement the HTA's broader policy framework on relevant material, a list has been produced to provide stakeholders with guidance on whether specific materials fall within the definition of relevant material under the HT Act.

Please see the supplementary list of materials for the purposes of the Human Tissue Act 2004.

We have reviewed the definition of relevant material for the human application sector, and have provided more information in our supplementary list of materials under the 2007 Quality & Safety Regulations.

[updated 13 July 2009]